MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71953-01

Device Problem Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2024

Event Type  malfunction  

Manufacturer Narrative

Reader (b)(6) has been returned and investigated.Visual inspection was performed on the returned reader and the reader was observed to be partially melted and black marks on the plastic channel were also observed.Visual inspection was performed on the returned usb/charging cable and burn marks were observed on the micro-usb side of the charging cable.The other side of the charging cable had no signs of damage or corrosion.The reader was sent for further investigation and de-cased.Visual inspection was performed on the readers pcba (printed circuit board assembly) and pcb (printed circuit board) and no signs of damage was observed.Damage to the usb shield was observed.The reader's returned battery was measured at 3.604v which is within specification of 3.6v-4.2v.A thermal camera was used to check for overheating components on the pcba.No overheating was observed when the reader was powered on, powered off, while scanning for sensor or during the reader's self test.The current draw of the reader was measured at 0.20ma, which is within specification of (0ma-3ma).A new un-used usb/charging cable was used and confirmed that the reader had proper charging capabilities and a successful connection to a pc, indicating the observed damage did not impact the functionality of reader.There was no evidence observed that would cause the reader to create fire, smoke, electric shock, or explosion.It was determined that an incorrect power adapter was used to charge the reader, resulting in damage to the usb cable and usb port.Since the current draw of the reader was within specification, it was determined that the reader did not have sufficient power to cause the observed damage.The dhrs (device history review) for the libre reader was reviewed and the dhrs showed the libre reader passed all tests prior to release.In addition, the review determined that the correct cable and adapter were part of the reader kit pack and there was no indication that the product did not meet specifications.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer reports visible smoke from their adc device.No further details are available at this time.There was no report of fire, explosion, or shock.Customer reports using the cable and adapter supplied by adc for use with the libre device.There was no report of death, serious injury, or mistreatment associated with this event.Issues involving thermal events occurring with adc freestyle libre and libre 2 readers is associated with report of corrections and removal number 2954323-02/09/23-001-c, submitted to the fda on 09-feb-23.Adc field action fa1005-2023 was issued to the us 09feb23.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 19064137
• MDR Text Key: 339666714
• Report Number: 2954323-2024-11863
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599803001
• UDI-Public: (01)00357599803001(10)01D231D
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 71953-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: QUALITY RECORD QR869779
• Patient Sequence Number: 1